Dec 24, 1992 - Guidance on whether "patch test kits" are exempt from the labeling requirements of HCS.Dec 24, 1992 - Guidance on whether "patch test kits" are exempt…
The Home page of ILPI's Safety Data Sheet (SDS) Resource, the leader in SDS information since 1995!
The history and philosophy behind this resource.
A curated collection of books and reference materials concerning Safety Data Sheets and closely related topics.
Paste your plain text SDS into the SDS-Demystifier, and it will be converted into a hypertext-enriched document with links to detailed explanations of each key term.
An extensive list of frequently asked questions about Safety Data Sheets including regulations, content, compliance, and more.
A humorous take on Safety Data Sheet jargon. Fill in the blanks on our entry form to generate a personalized Unsafety Data Sheet to share with your coworkers.
Since 1995, we've maintained this massive curated list of the best places to find Safety Data Sheets on the Internet.
Way more than a glossary, this hypertext-enhanced resource covers hundreds of SDS-related terms and expert knowledge. Each entry includes both the SDS relevance and links to additional authoritative resources.
Archived results of Safety Data Sheet related polls taken by some of our millions of site visitors
You are here! The OSHA regulations behind SDS regulations, including the inspection guidelines and over 400 official interpretations letters under the Hazard Communication Standard
Commercial suppliers of SDS authoring and management software as well as cloud compliance services.
Commercial companies that will create SDS's for your specific needs as well as SDS translation companies.
Safety signs, banners, and scoreboards? Get yours at Safety Emporium!
OSHA Hazard Communication Letters of Interpretation
Guidance on whether "patch test kits" are exempt from the labeling requirements of HCS.
ILPI assessment: Label-only and full exemptions remain distinct; apply the complete current conditions
This letter addresses the obsolete 1987 version of the Hazard Communication Standard (HCS). Its main distinction remains useful: an FDA label exemption does not by itself waive SDS, program or training duties. Office and household products are not automatically outside HazCom simply because consumers can buy them.
Under the current HCS, apply the FDA/USDA label exemption, full current drug exemption and consumer-product exemption (FAQ explanation). The drug provision also covers manufacturer-packaged retail drugs and drugs for employees' personal consumption, not only solid final doses. The old statement about medical kits is not a blanket exemption for chemicals employees handle while treating others. Biological hazards themselves are excluded, but a preparation's separate chemical hazards still require evaluation. Use current information and training requirements and the immediate-access FAQ. OSHA marks its matching source corrected December 6, 2024.
This comparison with current requirements is not a finding that OSHA has formally withdrawn this letter. This assessment reflects editorial judgment informed by human review and AI assistance. It is an opinion, may contain errors or omissions, and is not an official OSHA determination. For guidance on how OSHA requirements apply to your circumstances, contact your local OSHA office.
OSHA's notice about interpretation letters
The following notice is published on OSHA's interpretation pages; it is general guidance, not a letter-specific withdrawal notice.
OSHA requirements are set by statute, standards and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at https://www.osha.gov.
You requested guidance on whether "patch test kits" are exempt from the labeling requirements of HCS. If the patch test kit and its contents are subject to the labeling requirements of the Federal Food, Drug and Cosmetic Act and are labeled in accordance with the Food and Drug Administration, the kit would be exempt from the labeling requirements of HCS. This exemption, found in 29 CFR 1910.1200(b)(5)(ii) [ILPI:Original HCS 1987 context (PDF) · Current HCS; now 1910.1200(b)(5)(iii)], only applies to labels; employers must still comply with all other provisions of the standard.
You also list several instances that you feel would be exempt from all of the requirements of HCS, which we will address in the order that you presented them:
Manufacturer supplied general office supply products, e.g., copier toner;
Chemicals such as copier toner in a business office, that are only used by employees incidentally in non-routine and isolated instances, are not covered by the standard. HCS would apply if copier toner was used by an employee whose job involves routine work with the toner. For example, employees who work in a copy room of an office or in a business establishment that professionally duplicates documents, must be trained and informed of hazards in accordance with HCS.
Manufacturer supplied consumer supply products, e.g., daily use of Windex to clean surfaces;
Consumer products are only covered by HCS if the employees who use them experience exposures that are of greater duration andfrequency than those of normal consumers, or if the product is not used in a manner that is consistent with normal consumer use.
A bottle of Windex could fall under the scope of chemicals that are covered by the company's HCS program if employees use the cleaner more frequently than normal consumer use, or if it is not used in the same manner that a normal consumer would use Windex. For example, cleaning staff who use the product repeatedly on a daily basis would need information on the hazards of Windex because they use the product more frequently than a normal consumer would.
FDA approved drugs and emergency medical kits; and
MSDSs must be readily accessible to all workers who may be exposed to hazardouschemicals during normal conditions of use or during foreseeable emergencies at their workplaces, including FDA approved drugs. Such drugs are not subject to the labeling requirements of HCS when they are labeled in accordance with FDA guidelines, as per 29 CFR 1910.1200(b)(5) [ILPI:Original HCS 1987 context (PDF) · Current HCS]. Unless otherwise exempted, they are subject to all other requirements of the standard.
Drugs that are in solid and final form for direct administration to the patient (i.e. tablets, pills or capsules) are completely exempt from the requirements of HCS, as per 29 CFR 1910.1200(b)(6) [ILPI:Original HCS 1987 context (PDF) · Current HCS]. Vaccines, whose hazards are biological rather than chemical, are also exempt from the standard.
Medical kits are exempt from the HCS requirements because they are intended for employee consumption, as per 29 CFR 1910.1200(b)(6)(vi) [ILPI:Original HCS 1987 context (PDF) · Current drug exemption; apply its actual conditions].
[ILPI note: At issuance: 1910.1200, 1987 expanded rule (PDF). The current drug exemption depends on the exact intended use and form. A kit used to treat other people is not automatically employee personal consumption; FDA labeling alone removes only the specified HCS label duty. Other chemical hazards remain relevant.]
Pharmaceutical sample medications.
Please see our answer to the question above. Sample medications are comparable to other FDA approved medications, and would be covered in the same manner.
We hope this information is helpful. If you have any further questions please contact the Office of Health Compliance Assistance at (202) 219-8036.
Sincerely,
Roger A. Clark, Director Directorate of Compliance Programs